Cannabinoid Medication for Adults With OCD

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StatusTamamlandı

Sponsorlar

New York State Psychiatric Institute

KLINIK SINAQ: NCT02911324

BioSeek: nct02911324

Açar sözlər

Mücərrəd

The purpose of this pilot research study is to test the effects of a medication called nabilone (Cesamet) in adults with obsessive-compulsive disorder (OCD). Participants will receive either nabilone on its own, or nabilone in combination with a form of cognitive-behavioral therapy (CBT) called exposure and response prevention (EX/RP). Nabilone is a synthetic cannabinoid and acts on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. Nabilone is approved by the FDA for the treatment of chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.

Tarixlər

Son Doğrulandı:	01/31/2020
İlk təqdim:	09/11/2016
Təxmini qeydiyyat təqdim edildi:	09/19/2016
İlk Göndərmə:	09/21/2016
Son Yeniləmə Göndərildi:	02/26/2020
Son Yeniləmə Göndərildi:	02/27/2020
İlk təqdim edilmiş nəticələrin tarixi:	01/09/2020
İlk təqdim edilmiş QC nəticələrinin tarixi:	02/26/2020
İlk göndərilən nəticələrin tarixi:	02/27/2020
Həqiqi Təhsilin Başlama Tarixi:	08/31/2016
Təxmini İlkin Tamamlanma Tarixi:	12/31/2018
Təxmini İşin Tamamlanma Tarixi:	12/31/2018

Vəziyyət və ya xəstəlik

Obsessive-Compulsive Disorder

Müdaxilə / müalicə

Drug: Nabilone

Behavioral: Nabilone and EX/RP

Faza

Faza 1/Faza 2

Qol Qrupları

Qol	Müdaxilə / müalicə
Experimental: Nabilone Will receive nabilone at 1 mg daily (BID) over 4 weeks.
Experimental: Nabilone and EX/RP Will receive nabilone at 1 mg daily (BID) plus therapist-guided Exposure and Response Prevention Therapy during 4 weeks.	Behavioral: Nabilone and EX/RP Exposure and Response Prevention Therapy (EX/RP) is a type of Cognitive-Behavioral Therapy for OCD that involves intentionally confronting situations that trigger obsessional distress while refraining from doing compulsions.

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar	18 Years Üçün 18 Years
Təhsilə Uyğun Cinslər	All
Sağlam Könüllüləri qəbul edir	Bəli
Kriteriyalar	Inclusion Criteria: - Age 18-60 - Physically healthy, not pregnant - Primary Obsessive-Compulsive Disorder (OCD) - Patient off all psychotropic (except selective serotonin reuptake inhibitors [SSRIs]) and other types of drugs likely to interact with nabilone - Ability to provide informed consent - Ability to tolerate a treatment free-period Exclusion Criteria: - History of any significant medical condition that may increase the risk of participation - Females who are pregnant or nursing - Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation (e.g. lifetime psychosis or bipolar disorder) - Current substance use disorder or positive urine toxicology at screening, or any adverse reaction to a cannabinoid - Patients already receiving EX/RP

Nəticə

İlkin nəticə tədbirləri

1. Change in Yale-Brown Obsessive Compulsive Scale [Baseline (Week 0) and Week 4]

Yale-Brown Obsessive Compulsive Scale (YBOCS) Minimum Value: 0 Maximum Value: 40 Higher scores indicate more severe symptoms Change in YBOCS is calculated by subtracting the Week 4 score from the baseline score

İkincili Nəticə Tədbirləri

1. Feasibility of Recruitment [Through study completion, an average of 1 year.]

Number of eligible participants recruited per month over a 1 year period.

Cannabinoid Medication for Adults With OCD

Açar sözlər

nabilone

cannabinoid

nausea

qusma

kənaf

kimyaterapiya